MK-2060 and Clopidogrel Co-administration Safety and Tolerability Study in Participants With End-Stage Renal Disease (ESRD) (MK-2060-008)

Recruiting at 3 trial locations

Overseen By Toll Free Number

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Merck Sharp & Dohme LLC

Must be taking: Clopidogrel

Must not be taking: Anticoagulants, Antiplatelets

Disqualifiers: Cancer, DVT, GI bleeding, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 8 days

12 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial requires that you continue taking clopidogrel, but you may need to stop other anticoagulant or antiplatelet medications, except for intradialytic heparin, which is allowed.

What is the purpose of this trial?

This trial tests MK-2060, a new drug to prevent blood clots, in patients with severe kidney disease. It is used with clopidogrel, a common anti-clotting medication. The goal is to see if this combination is safe and well-tolerated.

Research Team

Medical Director

Principal Investigator

Merck Sharpe & Dohme LLC

Eligibility Criteria

Inclusion Criteria

Has End-Stage Renal Disease (ESRD) maintained on stable outpatient hemodialysis (HD) regimen at a healthcare center for > 3 months prior to dosing.

On HD regimen at least 3 times per week for a minimum of 3 hours per dialysis session, using a complication-free well-maintained AV fistula or AV graft.

Is taking clopidogrel for a minimum of 2 weeks prior to the first dosing of MK-2060 administration.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-Treatment

Participants continue their established background therapy of daily 75 mg clopidogrel for 2 weeks

2 weeks

Treatment

Participants receive 25 mg MK-2060 intravenous (IV) infusion on days 1, 3, 5, and 8 while continuing background therapy

8 days

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to approximately 104 days

Treatment Details

Interventions

• MK-2060

Participant Groups

Group I: MK-2060 Experimental Treatment 1 Intervention

Participants continued their established background therapy of daily 75 mg clopidogrel for 2 weeks (days -14 to 0). Participants then continued background therapy while receiving 25 mg MK-2060 intravenous (IV) infusion on days 1, 3, 5, and 8.

Who Is Running the Clinical Trial?

Merck Sharp & Dohme LLC

Lead Sponsor

Trials

4,096

Recruited

5,232,000+

Chirfi Guindo

Merck Sharp & Dohme LLC

Chief Marketing Officer since 2022

Degree in Engineering from Ecole Centrale de Paris, MBA from New York University Stern School of Business

Robert M. Davis

Merck Sharp & Dohme LLC

Chief Executive Officer since 2021

JD from Northwestern University Pritzker School of Law, MBA from Northwestern University Kellogg Graduate School of Management, Bachelor's in Finance from Miami University